Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
CAPECITABINE
Actavis Group PTC ehf
L01BC06
CAPECITABINE
150 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues
Authorised
2012-09-07
CAPECITABINE ACTAVIS 150 MG FILM-COATED TABLETS CAPECITABINE ACTAVIS 500 MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER capecitabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT CAPECITABINE ACTAVIS IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE ACTAVIS 3 HOW TO TAKE CAPECITABINE ACTAVIS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE CAPECITABINE ACTAVIS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT CAPECITABINE ACTAVIS IS AND WHAT IT IS USED FOR Capecitabine Actavis belongs to the group of medicines called “cytostatic medicines”, which stop the growth of cancer cells. Capecitabine Actavis contains capecitabine, which itself is not a cytostatic medicine. Only after being absorbed by the body is it changed into an active anti‑cancer medicine (more in tumour tissue than in normal tissue). Capecitabine Actavis is used in the treatment of colon, rectal, gastric, or breast cancers. Furthermore, Capecitabine Actavis is used to prevent new occurrence of colon cancer after complete removal of the tumour by surgery. Capecitabine Actavis may be used either alone or in combination with other medicines. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPECITABINE ACTAVIS DO NOT TAKE CAPECITABINE ACTAVIS: • if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6). You must inform your doctor if you know that you have an allergy or over‑reaction to this medicine, • if you previously have had sever Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Capecitabine Actavis 150 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg capecitabine. Excipient with known effect: 12.3 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pink coloured, capsule shaped, biconvex, film coated tablets (approx. 11.1 mm x 5.6 mm), debossed with “150”on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Capecitabine is indicated for the treatment of: for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). metastatic colorectal cancer (see section 5.1). first - line treatment of advanced gastric cancer in combination with a platinumbased regimen (see section 5.1). in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Capecitabine should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products. Careful monitoring during the first cycle of treatment is recommended for all patients. Treatment should be discontinued if progressive disease or intolerable toxicity is observed. Standard and reduced dose calculations according to body surface area for starting doses of Capecitabine of 1250 mg/m 2 and 1000 mg/m 2 are provided in tables 1 and 2, respectively. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочитайте повний документ